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dc.contributor.authorWinthrop, Kevin L
dc.contributor.authorNash, Peter
dc.contributor.authorYamaoka, Kunihiro
dc.contributor.authorMysler, Eduardo
dc.contributor.authorKhan, Nasser
dc.contributor.authorCamp, Heidi S
dc.contributor.authorSong, Yanna
dc.contributor.authorSuboticki, Jessica L
dc.contributor.authorCurtis, Jeffrey R
dc.date.accessioned2021-11-02T05:49:24Z
dc.date.available2021-11-02T05:49:24Z
dc.date.issued2021
dc.identifier.issn1468-2060en_US
dc.identifier.doi10.1136/annrheumdis-2021-220822en_US
dc.identifier.urihttp://hdl.handle.net/10072/409685
dc.description.abstractBACKGROUND: Upadacitinib (UPA) is an oral Janus kinase (JAK) inhibitor approved for the treatment of rheumatoid arthritis (RA). JAK inhibitors have been associated with an increased risk of herpes zoster (HZ) in patients with RA. OBJECTIVES: To evaluate the incidence and risk factors for HZ in UPA-treated patients with RA from the UPA phase III clinical trial programme. METHODS: Exposure-adjusted incidence/event rates for HZ were determined in patients receiving UPA (monotherapy or combination therapy) in six randomised phase III trials (data cut-off on 30 June 2020). HZ incidence and event rates were also determined in patients receiving methotrexate (MTX) monotherapy or adalimumab (ADA) + MTX. Multivariable Cox regression analysis was used to identify HZ risk factors in UPA-treated patients. RESULTS: A total of 5306 patients were included in this analysis. The incidence rate of HZ/100 patient-years (95% CI) was 0.8 (0.3 to 1.9), 1.1 (0.5 to 1.9), 3.0 (2.6 to 3.5) and 5.3 (4.5 to 6.2), in the MTX monotherapy, ADA + MTX, UPA 15 mg and UPA 30 mg groups, respectively. The majority of HZ cases with UPA (71%) involved a single dermatome. Prior history of HZ and Asian region were HZ risk factors in UPA-treated patients. CONCLUSION: In the UPA phase III RA clinical programme, HZ incidence and event rates were higher with UPA versus ADA + MTX or MTX monotherapy, and higher with the 30 mg versus 15 mg dose. Patients from Asia and those with a history of HZ may be at increased risk of HZ while receiving UPA.en_US
dc.description.peerreviewedYesen_US
dc.languageengen_US
dc.relation.ispartofjournalAnnals of the Rheumatic Diseasesen_US
dc.subject.fieldofresearchClinical sciencesen_US
dc.subject.fieldofresearchImmunologyen_US
dc.subject.fieldofresearchPublic healthen_US
dc.subject.fieldofresearchcode3202en_US
dc.subject.fieldofresearchcode3204en_US
dc.subject.fieldofresearchcode4206en_US
dc.subject.keywordsarthritisen_US
dc.subject.keywordsautoimmune diseasesen_US
dc.subject.keywordsautoimmunityen_US
dc.subject.keywordsrheumatoiden_US
dc.titleIncidence and risk factors for herpes zoster in patients with rheumatoid arthritis receiving upadacitinib: a pooled analysis of six phase III clinical trialsen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationWinthrop, KL; Nash, P; Yamaoka, K; Mysler, E; Khan, N; Camp, HS; Song, Y; Suboticki, JL; Curtis, JR, Incidence and risk factors for herpes zoster in patients with rheumatoid arthritis receiving upadacitinib: a pooled analysis of six phase III clinical trials, Annals of the Rheumatic Diseases, 2021en_US
dcterms.dateAccepted2021-09-22
dcterms.licensehttps://creativecommons.org/licenses/by-nc/4.0/en_US
dc.date.updated2021-10-24T23:04:32Z
dc.description.versionVersion of Record (VoR)en_US
gro.description.notepublicThis publication has been entered in Griffith Research Online as an advanced online version.en_US
gro.rights.copyright© Author(s) (or their employer(s)) 2021. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License, which permits unrestricted, non-commercial use, distribution and reproduction in any medium, providing that the work is properly cited.en_US
gro.hasfulltextFull Text
gro.griffith.authorNash, Peter


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